Kornimate/medical-research-clean huggingface dataset:
glutathione and health with post-polio syndrome

Conditions: Post-polio Syndrome; Physical Activity; Depression; Pain; Sleep Disorders

Summary: in this study, people who have symptoms of post polio will take oral glutathione supplements for three months. their levels of fatigue, physical activity and sleep efficiency will be assessed.

subjects will take a glutathione supplement by mouth for three months after an initial medical visit, blood draw and physical exam. there are four timepoints during the three months when subjects will fill out surveys and record food intake and sleep times in diaries for seven days. they will also wear a small device for seven days, a sensewear monitor that records physical activity, body temperature and other measures. after the fourth timepoint they will return to the medical center for another physical exam and blood draw. physicians trained in physical medicine and rehabilitation will be monitoring the study.

Eligibility criteria:
inclusion criteria: * ability to walk 100 feet with usual assistive devices (ex. cane or walker) * having a function score of 18-32 when tested with the ipps (index of post- polio sequelae). this will include people with post-polio symptoms in a very specific range of severity. exclusion criteria: * having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus) * currently taking glutathione or other antioxidants

Keywords: disability polio rehabilitation wellness
a study of loading doses of intravenous bondronat (ibandronate) in patients with breast cancer and metastatic bone disease.

Conditions: Pain; Bone Neoplasm; Neoplasm Metastasis

Summary: this single arm study will assess the efficacy of loading doses of intravenous bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. patients will receive an intravenous infusion of 6mg bondronat on days 1, 2 and 3. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * breast cancer; * bone metastases; * mean worst pain score \>=4 during 3 day baseline period; * stable dose of analgesics over a 3 day baseline period; * adequate renal function. exclusion criteria: * bisphosphonate treatment within 3 weeks of study enrollment; * a change in antineoplastic treatment within 6 weeks of study enrollment; * bone radiation within 2 weeks of study enrollment; * active infection.
obesity, lifestyle and work intervention

Conditions: Obesity; Morbid Obesity; Sick-leave; Work Related Illnesses; Life Style

Summary: the main aim of this study was to examine whether introducing a work intervention into a traditional lifestyle rehabilitation program for persons with bmi above 30, would affect the participants' ability to work and their lifestyle change. the investigators wanted to find out how the participants experienced their health, workability and work capacity, quality of life, diet and self-efficacy before and during the intervention

the background for this study was insights about obesity and sick leave. obesity is related to lower labor force participation, increased sickness absence and reduced productivity. a danish study from 2006 reported a yearly 1, 8 million extra days of work absence and close to 1.100 cases of disability pension related to obesity. a 2016-report from oecd show that persons with obesity between the ages 50-59 have three times as much work absence as those who do not struggle with obesity. this indicates that persons with obesity are a group where the need for work rehabilitation is important. despite this connection, work focus has not been a part of lifestyle interventions for persons with morbid obesity until the last two years. by introducing a work intervention into a traditional lifestyle rehabilitation program for persons with bmi over 30, the investigators wanted to examine whether this would affect the participants' ability to work and their lifestyle change. the study was designed as a randomized controlled study with an exploring prospective design. the intervention lasted 12 months and each patient had three visits (baseline, 6 and 12 months) at muritunet, each lasting 4-2-2 weeks. the participants were randomized into two intervention, one with work intervention and one without. data material gathered at each stay consisting of self-reported forms, test, journal and individual interviews. these were all collected at baseline, and at six and twelve months.

Eligibility criteria:
inclusion criteria: * participants with a body mass index (bmi) \> 30 with or without comorbidity exclusion criteria: * people without a capacity to consent. * people with severe alcohol and/or drug abuse. * people with a major mental illness. * being pregnant. * people with a health condition that contraindicates physical activity. * people with or plan to apply for disability benefits. * people with permanently adapted work.

Keywords: obesity work focus workability life-style treatment
long-term immune persistence of gsk biologicals' combined hepatitis a & b vaccine injected according to a 0,1,6 mth schedule in healthy adults

Conditions: Hepatitis B; Hepatitis A

Summary: the aim of this study is to evaluate the long-term persistence of hepatitis a and b antibodies at years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis a/hepatitis b vaccine. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007. this protocol posting deals with objectives \& outcome measures of the extension phase at year 11-15.

this is a long-term follow-up study at years 11, 12, 13, 14 and 15 after primary vaccination with gsk biologicals' hepatitis a/hepatitis b vaccine (three-dose schedule with 3 different lots). to evaluate the long-term antibody persistence, volunteers will be bled at years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-hav and anti-hbs antibody concentrations. no additional subjects will be recruited in the course of this extension study. if a subject has become seronegative for anti-hav antibodies or lost anti-hbs seroprotection concentrations at the long-term blood sampling time point (i.e. years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Eligibility criteria:
inclusion criteria: * subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points * written informed consent will have been obtained from each subject. before the blood sampling visit of each year.

Keywords: twinrix™ adult hepatitis a hepatitis b
a study in adult patients with type i, iii or iv osteogenesis imperfecta treated with bps804

Conditions: Osteogenesis Imperfecta, Type I; Osteogenesis Imperfecta Type III; Osteogenesis Imperfecta Type IV

Summary: the purpose of this study is to select a suitable dose of bps804 by measuring the strength/quality of bone using a special type of ct scanner. participants will be treated for 12 months and followed up for a further 12 months.

this study was previously posted by mereo biopharma and was transferred to ultragenyx in february 2021.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of oi type i, iii or iv with a confirmed defect in the col1a1/col1a2 genes, as confirmed by genetic testing * one or more fractures in the past 5 years * capable of giving signed consent exclusion criteria: * history of skeletal malignancies or other bone diseases (other than oi) * history of neural foraminal stenosis (except if due to scoliosis) * history of myocardial infarction, angina pectoris, ischaemic stroke or transient ischaemic attack * history of endocrine or thyroid/parathyroid conditions that could affect bone metabolism * treatment with bisphosphonates within 3 months of randomisation * treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation

Keywords: osteogenesis imperfecta brittle bone disease
quantifying lung tumor movement under deep inspiration breath holds

Conditions: Lung Cancer

Summary: radiotherapy is a common treatment for lung cancer. one challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. in some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. one way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. by doing this, a patient's lung tumor may not move as much as it would during regular breathing. in this study, the investigators aim to study patients with lung cancers which move during breathing. patients will be asked to hold their breath after inspiration while a ct scan of their lung tumor is obtained. the purpose of this study is to study how much less patients' lung tumors move when they hold their breath


Eligibility criteria:
inclusion criteria: * biopsy confirmed primary lung cancer * undergoing radiotherapy or chemoradiotherapy * able to perform adequate deep inspiration breath hold * patients of childbearing potential must practice adequate contraception * signed study-specific informed consent form exclusion criteria: * unable to perform adequate deep inspiration breath hold * prior tumor resection * prior chest or neck rt * pregnant

Keywords: lung cancer tumor motion
a study of imc-a12 (cixutumumab) with and without other standard chemotherapies in participants with lung cancer who have not received chemotherapy before

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

participants with stage iiib or iv non-small cell lung cancer (nsclc) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus \[vs.\] nonsquamous).

Eligibility criteria:
inclusion criteria: * has histologically or cytologically confirmed, stage iiib - iv nsclc * has metastatic disease * has a tumor measurable according to response evaluation criteria in solid tumors (recist) * has adequate hematologic function * has adequate hepatic function * has adequate renal function * women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation exclusion criteria: * has uncontrolled brain metastases * has leptomeningeal disease * has received previous chemotherapy for nsclc (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization) * receiving any other investigational agent(s) * has a history of treatment with other agents targeting the insulin-like growth factor (igf) or the epidermal growth factor (egf) receptor * has a known allergy / history of hypersensitivity reaction to any of the treatment components * has poorly controlled diabetes mellitus. participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range \[fasting glucose \<160 milligrams per deciliter (mg/dl) or below the upper limit of normal (uln) and hemoglobin a1c≤ 7%\] and that they are on a stable dietary or therapeutic regimen for this condition * has an uncontrolled intercurrent illness * pregnant or lactating * has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years * has superior vena cava syndrome contraindicating hydration * has current clinically-relevant coronary artery disease (new york heart association iii or iv) or uncontrolled congestive heart failure * has any national cancer institute common toxicity criteria for adverse events (nci-ctcae) version (v) 3.0 grade ≥2 peripheral neuropathy * has significant third space fluid retention, requiring repeated drainage

Keywords: tumors antibodies, monoclonal stage iiib metastatic non-small cell lung cancer stage iv metastatic non-small cell lung cancer
effect of qi gong training on quality of life in patients with systemic lupus erythematous (luqi)

Conditions: Lupus Erythematosus, Systemic

Summary: systemic lupus erythematosus (sle) is chronic and systemic autoimmune disease that mainly affecting women and leading to organ damages especially skin, joints, kidneys, central nervous system and heart. in sle, immune system dysfunction leads to autoantibodies, autoreactive t cells and pro-inflammatory cytokines production. these elements will initiate and maintain organ damages. patients with sle have disease flares followed by period of remission. flares can occur because of stress, infections, surgery, pregnancy or ultraviolet exposition. furthermore the chronic nature of sle is an important factor of depression in these patients. qi gong is an ancient chinese practice based on relaxation movements, posture and breathing in order to harmonize the body and mind. this practice improves the general state by reducing fatigue and improving sleep. the beneficial effect of qi gong in medicine has been studied in several diseases including cancer, diabetes, arterial hypertension and fibromyalgia. qi gong seems interesting in depressed patients but also to reduce stress in healthy subjects. the aim of this study is to evaluate the effects of qi gong on quality if life in patients with sle. patients will have two lessons of 60 minutes per week for three months and a collective lesson of 90 minutes per week for three months. the teacher of qi-gong will evaluate adherence to the practice of qi gong every week. clinical and biological data will be collected at baseline and at 2th, 4th, 6th, 9th and 12th month. different evaluation scores and neurotrophin levels will be collected at baseline and at 6th month.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus (sle) according the american rheumatology association (ara) and/or systemic lupus international collaborating clinics (slicc) criteria * free and clarified consent term signature. exclusion criteria: * patients who have other rheumatologic diseases (rheumatoid arthritis, sjogren syndrome, fibromyalgia, ankylosis spondylitis); * systemic lupus erythematosus disease assessment index (sledai) \> 5; * patients with malignancy; * patients who do not accept the study rules as time and/or follow-up exercise program time proposed; * suspected or pregnancy confirmation; * patients with inability or unwillingness to understand and/or sign informed consent

Keywords: systemic lupus erythematous qi gong quality of life
diets in symptom relief and the influence of quality of life in people with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: subjects with confirmed diagnosis of irritable bowel syndrome will be blinded and randomly assigned to one of two groups, the low fodmap diet or the conventional ibs diet group. they will be referred to do three hydrogen breath tests prior to diet education. upon completion, subjects will attend dietitian consultations at week 0, 6 and 10 for diet assessment, education and reinforcement. at week 4 and 8, dietitians will telephone patients to check on diet compliance and answer any diet question. two sets of questionnaires, the ibs global improvement scale and the ibsqol will be given to patients to complete before each dietitian visit at week 0, 6 and 10. two sample t-test and chi square test will be used to test the difference between the two groups and the association between breath tests results and responds to the two diets.

1. subjects who are interested will be interviewed and screened for ibs with rome ⅲ criteria by the principle investigator. research information will be explained in length and consent form will be signed if they agreed to participate 2. subjects will be blinded and randomly assigned to conventional ibs diet group (a) or low fodmap diet group (b) 3. 3 breath tests (lactulose, fructose, lactose) will be carried out for all subjects before diet education 4. subjects will be asked to come to the dietitians clinic and receive the first one hour diet education (including diet assessment \& diet education) and two times thirty minutes follow-up appointments with the dietitians at week 0, 6 and 10, respectively 5. subjects will be asked to record their food intake and signs and symptoms onto a food record book 6. subjects will be asked to fill out the ibs global improvement scale and the ibsqol questionnaire at week 0, 6 \& 10 7. at week 4 and week 8, telephone interviews will be conducted by the dietitians to reinforce diets and answer diet questions 8. results of ibs global improvement scale and ibsqol questionnaire will be analyzed using two sample t-test to test the difference between control and treatment group 9. chi square test will be used to look at the association between breath tests results and responds to the two diets

Eligibility criteria:
inclusion criteria: * adults \>18 years * confirmed ibs (after meeting rome ⅲ criteria) * hong kong chinese exclusion criteria: * age \<18 years * pregnancy * other ethnicities besides hong kong chinese * significant gi co-morbidities such as inflammatory bowel disease, coeliac disease, significant diverticular disease, history of gi cancer, gi resection and gi reconstruction
antenatal micronutrient supplementation and infant survival

Conditions: Infant Mortality; Preterm Birth; Low Birth Weight; Neonatal Mortality; Perinatal Mortality

Summary: the purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern bangladesh.

maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. we aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the unicef antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in bangladesh. over the duration of 2-3 years a community-surveillance in the northwestern, rural districts of gaibandha and southern rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. in a \~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. the trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in south asia.

Eligibility criteria:
inclusion criteria: * pregnant and consents to participate exclusion criteria: * not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing

Keywords: micronutrients deficiency pregnancy birth outcomes infant mortality neonatal mortality malnutrition antenatal
transcutaneous co2 measurement - from hospital to home

Conditions: Type 2 Respiratory Failure; Hypercapnic Respiratory Failure

Summary: long-term non-invasive ventilation (lt-niv) is the main treatment modality for chronic hypercapnic respiratory failure.to assess the adequacy of alveolar ventilation during sleep and potential sleep hypoventilation, nocturnal transcutaneous co2 (ptcco2) monitoring is necessary. there is an increased tendency to monitor patients at home, but there is a lack of robust data comparing the technical success rates between the home and inpatient setting of ptcco2 monitoring. the primary aim of the current study was to evaluate the rate of successful nocturnal ptcco2 monitoring in a home setting in a population of patients with chronic hypercapnic respiratory failure receiving lt-niv. the secondary aim was to compare these data with ptcco2 registrations performed during regular follow up of a similar population of patients in a hospital setting.

patients scheduled for lt-niv follow-up at oslo university hospital, ullevål in the time-period january 2020 to december 2022 were prospectively identified. follow-up monitoring occurred either at home or in the hospital. two physicians blinded to the location of the monitoring, retrospectively classified the ptcco2 as successful or unsuccessful, and identified the causes of failure for the latter.

Eligibility criteria:
inclusion criteria for both groups were: 1. lt-niv treatment for at least 3 months, 2. that the monitoring was due to a scheduled follow-up appointment, 3. at least one follow-up visit at the hospital after lt-niv initiation. inclusion in the study required a signed consent from all participants. there were three additional criteria for the home monitoring group: 1. home address in reasonable proximity to the hospital, 2. the subject/spouse/assistant/home health care provider was assumed capable of operating the equipment, and 3. the subject consented to undertaking the monitoring at home.
treatment (compassionate) use of device - pk papyrus

Conditions: Pseudoaneurysm, Carotid; Pseudoaneurysm

Summary: the purpose of this study is to evaluate the clinical use of the pk papyrus coronary stent graft system, a humanitarian use device (hud) approved by the fda under a humanitarian device exemption.


Eligibility criteria:
inclusion criteria: 1. patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery. exclusion criteria: 1. patients from special populations including individuals who are not yet adults (infants, children, teenagers). 2. adults who are cognitively impaired, pregnant women, and prisoners.